The drugs have benefits and downsides. Here’s an overview of how they work and how they will affect future leukemia treatment.

Arzerra: A New Therapy for CLL Patients

The FDA has approved Arzerra (ofatumumab) for people with chronic lymphocytic leukemia who haven’t had success from other forms of chemotherapy. About 16,000 people are diagnosed with CLL and about 4,400 die every year from the disease. It affects immune cells in the body called B-cells and tends to affect people after age 50.

Arzerra is a type of treatment called a “monoclonal antibody” that works by binding to certain proteins on B-cells, both the normal and cancer cells, so the immune system can better fight them.

Because Arzerra was approved under the FDA accelerated approval program, it needs further research. But Arzerra was successful at helping 59 patients with CLL who weren’t responding to other treatment.

Pros: Arzerra is more effective at killing leukemia cells than another antibody that has been approved for several years, says William G. Wierda, MD., associate professor and clinical medical director in the department of leukemia at the University of Texas MD Anderson Cancer Center in Houston.

The biggest potential pro is that Arzerra is helping a subpopulation of people with CLL — called refractory patients — who are resistant to standard chemotherapy, Dr. Wierda says. In these patients, only about 20 percent have responded to treatment in the past with a survival rate of nine months. But research has shown that Arzerra has a 50 percent response rate with a survival rate of 15 months, he says.

Cons: There aren’t any side effects to Arzerra that you won’t see with other drugs, Wierda says. When it’s being given intravenously, it can cause fever, a drop in blood pressure, shortness of breath, and chills, he says. “It’s usually worst during the first infusion,” he says, but the side effects can be treated with medication.

And because these patients have already taken other therapies that have failed, they’re at extremely high risk for all types of infections like pneumonia, he says.

Wierda calls the approval of Arzerra an “incremental improvement.” “It’s not a giant leap ahead,” he says, but it is progress toward where researchers are hoping to be in terms of treating patients with leukemia.

Rituxan: Improving Overall Survival for Those Under 70

In February 2010, CLL patients were given another treatment option: Rituxan (rituximab). Like Arzerra, it binds to cancer cells to weaken them and make them more susceptible to an attack by the immune system.

This drug is approved for people receiving CLL treatment for the first time as well as for those who have been treated in the past.

A study of 817 people who were receiving their first treatment for CLL found that combining Rituxan with chemotherapy put them into remission for eight months longer than people who only received chemotherapy, according to the FDA. Another study of 522 people who had already been given chemotherapy, found that taking another round of chemotherapy along with Rituxan helped lengthen remission by five months.

But Rituxan has real promise when it’s combined with two other drugs: the chemotherapy drugs Fludara (fludarabine) and Cytoxan (cyclophosphamide), Wierda says. One study found that combining the three drugs helped those patients stay in remission for 51 months, which is18 months longer than those who received only Fludara and Cytoxan, he says.

Also, people who took the three-drug combination lived longer. “That’s the first time we’ve seen a survival advantage,” he says. Other treatments have only improved the length of remission but not increased lifespan.

Pros: The 51-month remission that doctors are seeing with the three-drug combination is the longest remission they’ve seen with any front-line therapy, Wierda says. Fludara, when given by itself, helps patients go into remission for 24 months, he says, so combining the three drugs doubles the length of remission.

Cons: Combining Rituxan with the two other drugs can cause low blood counts, which can lead to infection, fatigue, and bleeding. “That’s particularly difficult for older patients,” Wierda says. Unfortunately, Rituxan did not show a real advantage for use in the elderly population, age 70 and over.

Also, people who have had a previous infection with hepatitis B risk having a reactivation of the virus when they take Rituxan and the other drugs.

And a small percentage of people can have long-term bone marrow damage from taking Cytoxan, which can develop into other blood disorders, Wierda says. “It happens in a very small percentage of patients, but it’s still a risk,” he says.

Now that Rituxan has been approved, giving it in combination with Fludara and Cytoxan to patients under 70 should be considered the standard of care, Wierda says.

This site complies with the HONcode standard for trustworthy health information: verify here.

Advertising Notice

This Site and third parties who place advertisements on this Site may collect and use information about
your visits to this Site and other websites in order to provide advertisements about goods and services of
interest to you. If you would like to obtain more information about these advertising practices and to make
choices about online behavioral advertising, please click here.